FDA label dce3c604-574d-9b1d-e053-2a95a90a0510

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID: dce3c618-85cc-0668-e053-2a95a90af4f7
SPL ID: dce3c604-574d-9b1d-e053-2a95a90a0510
Version: 1
Effective date: 2022-04-17
Source export date: 2026-09-28
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:34:55

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		dce3c604-574d-9b1d-e053-2a95a90a0510	id
spl set id		dce3c618-85cc-0668-e053-2a95a90af4f7	set_id

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

For external use only When using this product ■ do not exceed the recommended daily dosage unless directly by a doctor ■ do not put into the rectum by using fingers or any mechanical device or applicator ■ avoid contact with eyes ■ rinse with water to remove ■ do not swallow ■ do not store at temperature above 120 degree F

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.